spravato rems phone number
Further information, including a list of certified pharmacies, is available at www.SPRAVATOrems.com or 1-855-382-6022. Opt-In. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®. • Alternatively, a provider can contact OptumRx prior authorization by phone at 1-800-711-4555 to initiate a prior authorization review. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions. SPRAVATO® is intended for use only in a certified healthcare setting. Spravato Available Dosage Forms: 1. What are the possible side effects of SPRAVATO®? Proper Use. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. A REMS is a strategy to manage known or potential risks associated with a drug and is required by the U.S. Food and Drug Administration (FDA) to ensure that the benefits of the drug outweigh its risks. After administering Spravato, individuals must be monitored by a healthcare provider for at least 2 hours after administration. Because of the risk of serious adverse effects resulting from excessive sedation, esketamine is only available through a restricted program called SPRAVATO REMS. Your healthcare provider will help you complete this form and provide you with a copy. • Phone Payer Status • Product Acquisition Method • REMS Certification Status • Address • Pharmacy Type • Link to Form, if applicable • Pharmacy Notes Patient insurance benefits investigation is provided by third-party service providers for Janssen CarePath, under contract with Johnson & Johnson Health Care Systems Inc. on behalf of are pregnant or plan to become pregnant. However, we cannot recommend treatment or offer medical advice on personal health matters. Patients must be enrolled in the REMS program and educated on the risks of the drug. Company: Janssen Pharmaceuticals, Inc. Fax: 1-877-778-0091, Healthcare providers should report suspected adverse events or product quality complaints associated with SPRAVATO® to Janssen at 1-800-JANSSEN (1-800-526-7736) or the FDA at 1-800-FDA-1088 or online at www.fda.gov/medwatch. Spravato has a shiny new website and everything! Only healthcare settings, pharmacies, and patients enrolled in the program can prescribe, dispense, and receive SPRAVATO™. The goal of the REMS is to mitigate the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO administration, and abuse and misuse of SPRAVATO by: Ensuring that SPRAVATO is only dispensed and administered to patients in a medically supervised healthcare setting that monitors these patients Please consult your local payer for specific coding policies or call Janssen CarePath for assistance at 877-CarePath (877-227-3728). SPRAVATO is available only through a restricted program under a REMS called the SPRAVATO REMS because of the risks of serious adverse outcomes from sedation, dissociation, and abuse and misuse [see Boxed Warning and Warnings and Precautions (5.1, 5.2, 5.3)].Important requirements of the SPRAVATO REMS include the following:Healthcare settings must be certified in the program and … For patients to receive this medication, all doctors, pharmacists, and patients must agree to, understand, and carefully follow the requirements of the Spravato REMS Program. Keep all follow-up visits with your healthcare provider as scheduled. You should not breastfeed during treatment with SPRAVATO, Your healthcare provider will tell you how much SPRAVATO, During and after each use of the SPRAVATO, You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO, If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO, feeling disconnected from yourself, your thoughts, feelings and things around you, decreased feeling of sensitivity (numbness). Tell your healthcare provider if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings. SPRAVATO® (esketamine) nasal spray CIII is available only through a restricted distribution program called the SPRAVATO® REMS because of the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO administration, and abuse and misuse of SPRAVATO. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico. Janssen Pharmaceuticals, Inc. recognizes that the internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. In your response to us, please provide your name and the e‑mail address or phone number at which you receive reminders from us. (Risk Evaluation and Mitigation Strategy). Please note that this third-party website is not controlled by Janssen or subject to our Privacy Policy. Healthcare providers should report suspected adverse events or product quality complaints associated with SPRAVATO ® to Janssen at 1-800-JANSSEN (1-800-526-7736) or the FDA at 1-800-FDA-1088 or online at www.fda.gov/medwatch. Do not take part in these activities until the next day following a restful sleep. INSTRUCTIONS: 1. Review the SPRAVATO® Prescribing Information and the SPRAVATO® REMS Program Overview You are being directed to a third-party website: [extlink:external-url]. Third party trademarks used herein are trademarks of their respective owners. Please see full Prescribing Information, including Boxed WARNINGS, and Medication Guide for SPRAVATO® and discuss any questions you may have with your healthcare provider. Step 3: Space Identify Space for Administration and Monitoring. See “What is the most important information I should know about SPRAVATO®?”. It features a phone number you can dial to find out how and where to receive the treatment. These requirements apply in the United States. SPRAVATO® is intended for use only in a certified Healthcare Setting. Your REMS-certified SPRAVATO® treatment center will need a space with seating where patients can self-administer SPRAVATO® under the supervision of a trained healthcare provider. (REMS) called the SPRAVATO REMS [see Warnings and Precautions]. For VRS, visit Video Relay Services to sign up and give them the number 604-215-5101 to call us. Mail You may report side effects to FDA at 1-800-FDA-1088. Because of the risk for abuse and misuse, sedation, and dissociation, Spravato is only available through a program known as Spravato Risk Evaluation and Mitigation Strategy (REMS) Program. Call 8-1-1 toll-free in B.C., or for the deaf and hard of hearing, call 7-1-1 (TTY). Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. There’s a full website detailing their REMS program (Risk Evaluation and Mitigation Strategy). Some people may have a higher risk of having suicidal thoughts or actions. Phone Number: 281-619-8329 E-mail: contact@myhopetms.com Address: 6800 Harris Parkway Suite 200 B Fort Worth Texas 76132 Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO ® is only available through a restricted program called the SPRAVATO ® Risk Evaluation and Mitigation Strategy (REMS) Program. Please see the SPRAVATO ® Access & Reimbursement Guide for more information on coding and sample claim forms. Pharmacies must be certified in the REMS and must only dispense SPRAVATO ® to healthcare settings that are certified in the program. Tell your healthcare provider right away if you feel like you cannot stay awake or if you feel like you are going to pass out. Spravato can only be dispensed in healthcare settings. Taking SPRAVATO® with certain medicine may cause side effects. Pharmacies must be certified in the REMS and must only dispense SPRAVATO ® to healthcare settings that are certified in the program. Your healthcare setting information (name, location, and phone number) will be listed on a location finder, as a certified outpatient healthcare setting, available to healthcare professionals and patients seeking treatment with SPRAVATO®. The ultimate responsibility for patient care resides with a healthcare professional. SPRAVATO® can cause serious side effects, including: If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®. ... Spravato REMS Therapy New days lie ahead with Spravato for those with treatment resistant depression. In the U.S. 1. This information is intended for the use of patients and caregivers in the United States and its territories only. If you require immediate assistance or wish to report a side effect or product complaint, Janssen Medical Information can be reached by phone at 1-800-JANSSEN (1-800-526-7736) Monday-Friday, 9 AM - 8 PM ET. Phone. If you require immediate assistance or wish to report a side effect or product complaint, Janssen Medical Information can be reached by phone at 1-800-JANSSEN (1-800-526-7736) Monday-Friday, 9 AM - 8 PM ET. other unusual changes in behavior or mood, have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs), have an abnormal connection between your veins and arteries (arteriovenous malformation), are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO, slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting, history of brain injury or any condition where there is increased pressure in the brain. SPRAVATO® to Janssen at 1-800-JANSSEN or the FDA at 1-800-FDA-1088 or online at www.fda.gov/medwatch. If you have any questions about the SPRAVATO ® REMS or need help with certification or enrollment, call 1-855-382-6022 Monday - Friday 8AM - 8PM ET For SPRAVATO ® REMS Program information contact: Phone: 1-855-382-6022 Fax: 1-877-778-0091 SPRAVATO® may cause serious side effects including: The most common side effects of SPRAVATO® when used along with an antidepressant taken by mouth include: If these common side effects occur, they usually happen right after taking SPRAVATO® and go away the same day. Depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation or behavior. https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/, Adults with treatment-resistant depression (TRD), Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions. REMS-certified treatment center for SPRAVATO® treatment Select “I am the Prescribing & Treating Physician” if you plan to prescribe SPRAVATO® and treat the patient at your REMS-certified healthcare setting. © Janssen Pharmaceuticals, Inc. 2020. DSUVIA is intended for sublingual delivery only by a healthcare provider . Email. The REMS program also requires that you’re fully informed of the risks before taking Spravato. Call your doctor for medical advice about side effects. 5.4 SPRAVATO Risk Evaluation and Mitigation Strategy (REMS) SPRAVATO is available only through a restricted program under a REMS called the SPRAVATO REMS because of the risks of serious adverse outcomes from sedation, dissociation, and abuse and misuse [see Boxed Warning and Warnings and Precautions (5.1, 5.2, 5.3)]. It’s not a surprise that Janssen is being extra cautious with administration given the delicate nature of ketamine as a drug. Spravato must be administered at a REMS certified treatment center. SPRAVATO® REMS Resources PHARMACY • Inpatient Healthcare Setting Enrollment Form • REMS Program Overview • Prescribing Information • Pharmacy Enrollment Form • REMS Program Overview • Prescribing Information OUTPATIENT HEALTHCARE SETTING 8 Contact the SPRAVATO® REMS Phone: 1-855-382-6022 Fax: 1-877-778-0091 We look forward to assisting you, or your friends and family with your mental health needs. By clicking "Continue" you will exit the SPRAVATO® REMS website. Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. Application Number: 211243 Approval Date: 03/05/2019 Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. These are not all the possible side effects of SPRAVATO®. Phone: 1--2-22 www.SPRAVATOrems.com Fax: 1---1 Janssen Pharmaceuticals Inc. 00 08/0 Page 2 of 2 Phone: 1-855-382-6022
SPRAVATO, Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO, If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO, There is a pregnancy registry for women who are exposed to SPRAVATO, are breastfeeding or plan to breastfeed. If you prefer to correspond with us via regular mail, or have inquiries regarding vendor opportunities or marketing/product suggestions, please use the following address: Janssen Scientific Affairs Medical Information CenterPO Box 200Titusville, NJ 08560. Not… Suicidal Thoughts and Behaviors ... drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 1. You are encouraged to report negative side effects of prescription drugs to the FDA.Visit www.fda.gov/medwatch or call 1-800-FDA-1088. 3 ways to enroll SPRAVATO™ is an FDA approved prescription medicine, used with oral antidepressants, for treatment-resistant depression (TRD) and Major Depressive Disorder (MDD) with Suicidal Ideation in adults. amount paid for your SPRAVATO® medication. SPRAVATO ® can only be administered at healthcare settings certified in the SPRAVATO ® REMS Program. Common side effects of Spravato include nausea, reduced sense of touch and sensation, anxiety, lack of energy, vomiting, and feeling drunk. SPRAVATO® is available only through a restricted distribution program called the SPRAVATO® REMS because of the risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO® administration, and abuse and misuse of SPRAVATO®. Distributed by: Janssen Pharmaceuticals, Inc, Titusville, NJ 08560
Treatment-resistant depression (TRD) in adults. SPRAVATO® must never be dispensed directly to a patient for home use. For more information from the manufacturer about Spravato, click here. Some of the procedures in place for safety include: 1. Two hours of monitoring the patient’s condition and vital signs during and after drug administration. Inpatient Healthcare Settings must be certified in the SPRAVATO® REMS in order to treat patients with SPRAVATO®, Outpatient Healthcare Settings must be certified in the SPRAVATO® REMS in order to treat patients with SPRAVATO®, Pharmacies must be certified in the SPRAVATO® REMS in order to dispense SPRAVATO®, Patients must be enrolled in the SPRAVATO® REMS in order to receive SPRAVATO® treatment in an Outpatient Healthcare Setting, If you have any questions about the SPRAVATO® REMS or need help with certification or enrollment, call 1-855-382-6022Monday - Friday 8AM - 8PM ET, For SPRAVATO® REMS Program information contact:
This site is published by Janssen Pharmaceuticals Inc., which is solely responsible for its contents. Thank you for visiting our site. All rights reserved. What is the most important information I should know about SPRAVATO®? SPRAVATO® is a prescription medicine, used along with an antidepressant taken by mouth to treat: SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). Call our office at 612-869-4444 or email us at frontdesk@diamondlakeclinic.org to schedule an appointment and learn more about our services. This site is intended for use by healthcare professionals in the United States and Puerto Rico. Further information, including a list of certified pharmacies, is available at www.SPRAVATOrems.com or 1-855-382-6022. A REMS is a strategy to manage known or potential serious risks associated with a drug and is required by the Food and Drug Administration (FDA) to ensure the benefits of a drug outweigh its risks. 1 Enroll in the Savings Program By phone 877-CarePath (877-227-3728) By creating an online account and enrolling at MyJanssenCarePath.com By fax or mail Complete Patient Enrollment For m† †You will activate your card upon receipt of enrollment confirmation by mail. Your healthcare provider must monitor you for serious side effects for at least 2 hours after taking SPRAVATO. Once benefit coverage has been approved for Spravato under the pharmacy benefit, a prescription can be filled by the provider at any Spravato certified pharmacy within HealthLink BC, your provincial health line, is as close as your phone or the web any time of the day or night, every day of the year. Janssen will be happy to answer any general product-related questions. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.
Inpatient Healthcare Settings must be certified, Outpatient Healthcare Settings must be certified, Patients must be enrolled in the SPRAVATO, Inpatient Healthcare Setting Certification, Outpatient Healthcare Setting Certification. Please note that we can only provide information about products marketed within the United States, and must refer international inquiries to our affiliates. Table 1: Risk Differences of the Number of Patients with Suicidal Thank you for your interest in contacting Janssen Pharmaceuticals, Inc. If you do not want your information … If you have a question that relates to treatment of a personal medical condition, please contact your physician or healthcare professional, as this individual is most familiar with your specific medical condition and complete medical history. Phone Number. Drug information provided by: IBM Micromedex You will need to take a dose of this medicine under your doctor's supervision in a medical facility. Spravato can only be used under the direct observation of a healthcare provider. By checking, I agree to share my form responses and request a call back. What is SPRAVATO® (esketamine) CIII nasal spray? Laws, regulatory requirements and medical practices for pharmaceutical products vary from country to country. The material on this site is intended only as informational or as an educational aid and it is not intended to be taken as medical advice. Esketamine can only be administered at health care setting certified in the SPRAVATO REMS Program and to patients enrolled in the program. We hope your visit was informative. Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicines. ©Janssen Pharmaceuticals, Inc. 2020 08/2020. This link is provided for your convenience. have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true). pharmacist to receive savings on your SPRAVATO® medication costs. Submit this signed form by fax or mail along with your pharmacy receipt and, if required, prescription label from medication carton Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. Phone: 1-8-8-0 www.SPRAVATOrems.com Fax: 1-877-778-0091 anssen araceuticals Inc SPRAVATO™ is available only through the SPRAVATO™ REMS, a restricted distribution program. SPRAVATO® is intended for patient administration under the direct observation of a healthcare provider, and patients are required to be monitored by a healthcare provider for at least 2 hours. If your receipt includes a prescription number and does not include a Janssen medication name, also include a copy of your prescription label from the medication carton. So, once a health care provider determines that Spravato is an appropriate treatment option, the patients will be treated in accordance with the REMS. The Prescribing Information included here may not be appropriate for use outside the United States and its territories. Spray Therapeutic Class: Antidepressant Pharmacologic Class: N-Methyl-D-Aspartate Receptor Antagonist Because of these risks, esketamine is only available through a restricted program called the Spravato REMS Program. It is not known if SPRAVATO® is safe and effective in children. What should I avoid while taking SPRAVATO®? Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you: Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Please call: 1-800-JANSSEN (1-800-526-7736) Monday-Friday, 9 AM - 8 PM ET. Third party trademarks used herein are trademarks of their respective owners. Do not take Spravato if pregnant or breastfeeding. It is very important that you understand the requirements of the Spravato™ REMS program, and become familiar with the Spravato™ medication guide and patient instructions. Please call: 1-800-JANSSEN (1-800-526-7736)Monday-Friday, 9 AM - 8 PM ET. This site is published by Janssen Pharmaceuticals, Inc., which is solely responsible for its contents. Spravato (esketamine) is a prescription medication used in conjunction with an oral antidepressant to treat treatment-resistant depression (TRD) in adults. Risks can include serious side effects such as sedation (sleepiness, trouble thinking clearly, or inability to drive or use heavy machinery) and dissociation (an “out-of-body” experience). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine. Call Janssen CarePath at 844-777-2828,Monday–Friday, 8:00 AM to 8:00 PM ET. It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions.